PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recalls

May 18, 2026

Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost E

Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection

May 18, 2026

Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD

Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection

April 30, 2026

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225),

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

April 30, 2026

Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

April 28, 2026

Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027),

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

April 28, 2026

Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 7222

Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.

April 28, 2026

Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

April 28, 2026

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079,

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

March 31, 2026

Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 7222

Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.

March 19, 2026

Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA d

Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.

March 5, 2026

Vue Motion V12. Product Number: 1017979.

Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.

March 3, 2026

Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Allura Xper FD20/20; System Code: 722038;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Allura Xper FD20/15; System Code: 722058;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Azurion 5 M12; System Code: (1)722227, (2)722231;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Allura Xper FD10C; System Code: 722001;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Allura Xper FD20/10; System Code: 722029;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Allura Xper FD20/20 OR Table; System Code: 722039;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

ALLURA Xper FD10F; System Code: 722002;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Allura Xper FD20/15 OR Table; System Code: 722059;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026

ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

January 26, 2026

Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026

Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026

Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026

Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026

Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026

Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026

Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026

Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

December 15, 2025

Allura Xper FD10; Model Number: 722026;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD20; Model Number: 722006;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD20 Biplane; Model Number: 722008;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD20; Model Number: 722012;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD20 OR Table; Model Number: 722023;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Product Name: Allura Xper FD10C; Model number: 722001;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD10/10; Model Number: 722027;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD20; Model Number: 722028;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD10; Model Number: 722003;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD20 Biplane; Model Number: 722013;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD10F; Model Number: 722002;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD10/10; Model Number: 722011;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD20/20; Model Number: 722038;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD10/10; Model Number: 722005;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD20/10; Model Number: 722029;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025

Allura Xper FD10; Model Number: 722010;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 12, 2025

Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azuri

Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

December 12, 2025

Philips Azurion system; Software Version Number: R3.1;

Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.

December 8, 2025

Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion

Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.

October 2, 2025

Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;

The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.

September 29, 2025

Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system

Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.

September 3, 2025

Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

September 3, 2025

Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

September 3, 2025

Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

August 8, 2025

IntelliSpace Cardiovascular, Software 8.0.0.4.

Software issue that results in the display of outdated information.

August 1, 2025

Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

August 1, 2025

Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/1

Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.

August 1, 2025

Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allur

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

June 30, 2025

Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028.

Potential for temporary loss of imaging (X-ray) functionality due to software issue.

June 4, 2025

Azurion 7 M20. Fluoroscopic X-Ray System.

Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

May 28, 2025

Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 7

A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

April 7, 2025

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

March 24, 2025

Intera 1.5T Power/Pulsar, Model Number: 781105;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

March 24, 2025

SmartPath to dStream for 1.5T, Model Number: 782146;

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.